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Clinical investigation to assess the safety and performance of the Organox Metra, for normothermic perfusion of livers, prior to transplantation and to compare with retrospective data from matched controls

Condition category

Surgery

Date applied

11/10/2012

Date assigned

27/11/2012

Last edited

06/04/2016

Prospective/Retrospective

Retrospectively registered

Overall trial status

Completed

Recruitment status

No longer recruiting

Plain English Summary

Background and study aimsThe OrganOx metra is an automated transportable device for preserving donated livers for transplantation. The aim of this study is to assess the safety and performance of the OrganOx Metra as an organ preservation method before liver transplantation.

Who can participate? Patients aged 18 or older on the waiting list for liver transplantation

What does the study involve? Participants receive liver transplants that have been preserved using the OrganOx metra device. The functioning of the transplanted liver and the patient survival rate are compared with the results from livers that were preserved using the conventional ice bucket method.

What are the possible benefits and risks of participating? This study may demonstrate the safety and performance of the OrganOx metra as a medical device for the preservation of livers before transplantation. It is hoped that there will be benefits in terms of both the quality and quantity of livers available for transplantation. We believe that this would reduce the waiting time for liver transplantation and improve outcomes for patients. Liver transplant surgery carries a risk of significant complications, including bile duct complications, bleeding, blood clots, infection, memory and thinking problems, and failure or rejection of the donated liver. Using the OrganOx Metra does not increase the level of risk to the patient.

Where is the study run from? Kings College Hospital (UK)

When is the study starting and how long is it expected to run for? October 2012 to December 2013

Who is funding the study? OrganOx Ltd (UK)

Who is the main contact? Dr Toni Daytoni.day@organox.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nigel Heaton

ORCID ID

Contact details

King's College Hospital Institute of Liver Studies London SE5 9RS United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ORG/NPL/001

Study information

Scientific title

Non-randomised, open-label, single-arm, prospective clinical investigation to assess the safety and performance of the Organox Metra, for normothermic perfusion of livers, prior to transplantation and to compare with retrospective data from matched controls

Acronym

Study hypothesis

To assess the safety and performance of normothermic perfusion as an organ preservation method prior to liver transplantation using the OrganOx Metra.

Primary study design

Secondary study design

Trial setting

Trial type

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Liver transplant

Intervention

Treatment arm 1: livers transplanted after preservation on the OrganOx metra device, the methodology for current clinical practice for liver transplantation is observed.

Treatment arm 2: Retrospectively collected data from livers transplanted after preservation using the conventional ice bucket, the methodology for current clinical practice for liver transplantation is observed.

Overall trial start date

11/10/2012

Overall trial end date

01/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Organ inclusion criteria1. Livers from male or female adult donors (18 years or greater)2. Accepted for transplantation using current (standard and extended) criteria3. Both heart-beating (DBD) and non-heart-beating (DCD) donor organs may be included

Recipient Inclusion criteria1. Male or female, aged 18 years or older2. On the waiting list for liver transplantation at Kings College Hospital, London.3. Provided informed consent for participation in the study4. Able and willing to comply with all study requirements (in the opinion of the investigator or nominated deputy)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

Organ exclusion criteria1. Livers offered from a donor hospital that is located more than 3 hours travelling time (by road) of both Kings College Hospital and Oxford.2. Donors in whom the liver is planned to be split.3. Donor livers that would not be accepted under current (Kings College Hospital) criteria.4. Livers taken from donors aged <18 years.5. Donors with high donor serum Na+ (> 160 mmol/litre) at the time of liver retrieval.

Recipient Exclusion criteriaThe participant may not enter the study if ANY of the following apply:1. Not willing to, unable or not capable to provide informed consent2. Recipients aged less ˂18 years3. Undergoing transplant for fulminant hepatic failure4. Undergoing re-transplantation.5. Undergoing transplantation of other organ(s) in addition to the liver6. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk by participating in the study, or may influence the result of the study, or the participants ability to participate in the study.7. Not suitable for any other reason, in the opinion of the Investigator, to take part in the study.8. Enrolled in clinical studies of other unlicensed therapy.9. Participated in another research study involving an investigational product in the previous 12 weeks.10. Pregnant or nursing mothers